FDA Adverse Event
Malfunction
Summary report: N
PORTEX BLUE LINE CUFFED ADJUSTABLE FLANGE TRACHEOSTOMY TUBES
MDR report key: 1901468
·
Received November 8, 2010
Report
- Report Number
- 2183502-2010-00521
- Event Type
- Malfunction
- Date Received
- November 8, 2010
- Report Date
- November 5, 2010
- Manufacturer
- SMITHS MEDICAL INTERNATIONAL LTD.
- Product Code
- JOH
- PMA / PMN Number
- K962175
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- EZ
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
MANUFACTURER COMPLETED THE ENTIRE FORM. CUSTOMER HAS NOT YET RETURNED THE DEVICE TO THE MANUFACTURER FOR DEVICE EVALUATION. WHEN AND IF THE DEVICE BECOMES AVAILABLE AND IS RETURNED AND EVALUATED THE MANUFACTURER WILL FILE A FOLLOW-UP REPORT DETAILING THE RESULTS OF THE EVALUATION.
Description of Event or Problem · 1
USER FACILITY REPORTED THAT THE PRODUCT WAS IN USE WITH PT. THE PRODUCT WAS FOUND TO BE LEAKING AND THE LEAKAGE SOURCE WAS CONFIRMED TO BE THE INFLATION LINE. USER REPORTED THE DEVICE WAS REMOVED AND REPLACED. NO INCIDENT RELATED MEDICAL SEQUELA REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | PORTEX BLUE LINE CUFFED ADJUSTABLE FLANGE TRACHEOSTOMY TUBES | TRACHEOSTOMY TUBE | JOH | SMITHS MEDICAL INTERNATIONAL LTD. | NA | 1699004 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK |